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Recommendations for Tumor Mutational Burden Assay Validation and Reporting: A Joint Consensus Recommendation of the Association for Molecular Pathology, College of American Pathologists, and Society for Immunotherapy of Cancer.
Furtado, Larissa V; Bifulco, Carlo; Dolderer, Daniel; Hsiao, Susan J; Kipp, Benjamin R; Lindeman, Neal I; Ritterhouse, Lauren L; Temple-Smolkin, Robyn L; Zehir, Ahmet; Nowak, Jonathan A.
Afiliação
  • Furtado LV; The Tumor Mutational Burden Working Group of the Clinical Practice Committee, Association for Molecular Pathology, Rockville, Maryland; Department of Pathology, St. Jude Children's Research Hospital, Memphis, Tennessee. Electronic address: larissa.furtado@stjude.org.
  • Bifulco C; The Tumor Mutational Burden Working Group of the Clinical Practice Committee, Association for Molecular Pathology, Rockville, Maryland; Department of Pathology, Providence Portland Medical Center, Portland, Oregon.
  • Dolderer D; The Tumor Mutational Burden Working Group of the Clinical Practice Committee, Association for Molecular Pathology, Rockville, Maryland; Department of Pathology, Jupiter Medical Center, Jupiter, Florida.
  • Hsiao SJ; The Tumor Mutational Burden Working Group of the Clinical Practice Committee, Association for Molecular Pathology, Rockville, Maryland; Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York.
  • Kipp BR; The Tumor Mutational Burden Working Group of the Clinical Practice Committee, Association for Molecular Pathology, Rockville, Maryland; Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
  • Lindeman NI; The Tumor Mutational Burden Working Group of the Clinical Practice Committee, Association for Molecular Pathology, Rockville, Maryland; Department of Pathology, Weill Cornell Medicine, New York, New York.
  • Ritterhouse LL; The Tumor Mutational Burden Working Group of the Clinical Practice Committee, Association for Molecular Pathology, Rockville, Maryland; Department of Pathology, Massachusetts General Hospital, Boston, Massachusetts.
  • Temple-Smolkin RL; Association for Molecular Pathology, Rockville, Maryland.
  • Zehir A; The Tumor Mutational Burden Working Group of the Clinical Practice Committee, Association for Molecular Pathology, Rockville, Maryland; Memorial Sloan Kettering Cancer Center, New York, New York.
  • Nowak JA; The Tumor Mutational Burden Working Group of the Clinical Practice Committee, Association for Molecular Pathology, Rockville, Maryland; Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts.
J Mol Diagn ; 26(8): 653-668, 2024 Aug.
Article em En | MEDLINE | ID: mdl-38851389
ABSTRACT
Tumor mutational burden (TMB) has been recognized as a predictive biomarker for immunotherapy response in several tumor types. Several laboratories offer TMB testing, but there is significant variation in how TMB is calculated, reported, and interpreted among laboratories. TMB standardization efforts are underway, but no published guidance for TMB validation and reporting is currently available. Recognizing the current challenges of clinical TMB testing, the Association for Molecular Pathology convened a multidisciplinary collaborative working group with representation from the American Society of Clinical Oncology, the College of American Pathologists, and the Society for the Immunotherapy of Cancer to review the laboratory practices surrounding TMB and develop recommendations for the analytical validation and reporting of TMB testing based on survey data, literature review, and expert consensus. These recommendations encompass pre-analytical, analytical, and postanalytical factors of TMB analysis, and they emphasize the relevance of comprehensive methodological descriptions to allow comparability between assays.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Biomarcadores Tumorais / Mutação / Neoplasias Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: J Mol Diagn Assunto da revista: BIOLOGIA MOLECULAR Ano de publicação: 2024 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Biomarcadores Tumorais / Mutação / Neoplasias Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: J Mol Diagn Assunto da revista: BIOLOGIA MOLECULAR Ano de publicação: 2024 Tipo de documento: Article